Articulating suturing device with improved actuation and alignment mechanisms

ABSTRACT

A vessel closure device that includes improved activation and alignment mechanisms that result in greater control and ease of use for the user.

BACKGROUND OF THE INVENTION

The present invention relates generally to apparatus and methods for thesuturing of body lumens. More particularly, the present inventionrelates to techniques for percutaneous closure of arterial and venouspuncture sites, which are usually accessed through a tissue tract.

A number of diagnostic and interventional vascular procedures are nowperformed translumenally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established duringthe well-known Seldinger technique, as described, for example, inWilliam Grossman's “Cardiac Catheterization and Angioplasty,” 3.sup.rdEd., Lea and Febiger, Philadelphia, 1986, incorporated herein byreference. Vascular access is generally provided through an introducersheath, which is positioned to extend from outside the patient body intothe vascular lumen.

When vascular access is no longer required, the introducer sheath isremoved and bleeding at the puncture site stopped. One common approachfor providing hemostasis (the cessation of bleeding) is to applyexternal force near and upstream from the puncture site, typically bymanual or “digital” compression. This approach suffers from a number ofdisadvantages. It is time consuming, frequently requiring one-half houror more of compression before hemostasis is assured. Additionally, suchcompression techniques rely on clot formation, which can be delayeduntil anticoagulants used in vascular therapy procedures (such as forheart attacks, stent deployment, non-optical PTCA results, and the like)wear off. This can take two to four hours, thereby increasing the timerequired before completion of the compression technique. The compressionprocedure is further uncomfortable for the patient and frequentlyrequires analgesics to be tolerable. Moreover, the application ofexcessive pressure can at times totally occlude the underlying bloodvessel, resulting in ischemia and/or thrombosis. Following manualcompression, the patient typically remains recumbent from four to asmuch as twelve hours or more under close observation to assure continuedhemostasis. During this time renewed bleeding may occur, resulting inblood loss through the tract, hematoma and/or pseudo-aneurysm formation,as well as arteriovenous fistula formation. These complications mayrequire blood transfusion and/or surgical intervention.

The incidence of complications from compression-induced hemostasisincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. It is clear that the compressiontechnique for arterial closure can be risky, and is expensive andonerous to the patient. Although the risk of complications can bereduced by using highly trained individuals, dedicating such personnelto this task is both expensive and inefficient. Nonetheless, as thenumber and efficacy of translumenally performed diagnostic andinterventional vascular procedures increases, the number of patientsrequiring effective hemostasis for a vascular puncture continues toincrease.

To overcome the problems associated with manual compression, the use ofbioabsorbable fasteners or sealing bodies to stop bleeding haspreviously been proposed. Generally, these approaches rely on theplacement of a thrombogenic and bioabsorbable material, such ascollagen, at the superficial arterial wall over the puncture site. Whilepotentially effective, this approach suffers from a number of problems.It can be difficult to properly locate the interface of the overlyingtissue and the adventitial surface of the blood vessel. Locating thefastener too far from that interface can result in failure to providehemostasis, and subsequent hematoma and/or pseudo-aneurysm formation.Conversely, if the sealing body intrudes into the arterial lumen,intravascular clots and/or collagen pieces with thrombus attached canform and embolize downstream, causing vascular occlusion. Also, thrombusformation on the surface of a sealing body protruding into the lumen cancause a stenosis, which can obstruct normal blood flow. Other possiblecomplications include infection, as well as adverse reaction to thecollagen or other implant.

A more effective approach for vascular closure has been proposed in U.S.Pat. Nos. 5,417,699, 5,613,974; and PCT published Patent Application No.PCT/US96/10271 filed on Jun. 12, 1996, the full disclosures of which areincorporated herein by reference. A suture-applying device is introducedthrough the tissue tract with a distal end of the device extendingthrough the vascular puncture. One or more needles in the device arethen used to draw suture through the blood vessel wall on opposite sidesof the puncture, and the suture is secured directly over the adventitialsurface of the blood vessel wall to provide highly reliable closure.

While a significant improvement over the use of manual pressure, clamps,and collagen plugs, certain design criteria have been found to beimportant to successful suturing to achieve vascular closure. Forexample, it is highly beneficial to properly direct the needles throughthe blood vessel wall at a significant distance from the puncture sothat the suture is well anchored in the tissue and can provide tightclosure. It is also highly beneficial to insure that the needledeployment takes place when the device is properly positioned relativeto the vessel wall. The ease of deployment and efficacy of the procedurecan further be enhanced by reducing the cross-section of that portion ofthe device that is inserted into the tissue tract and/or the vesselitself, which may also allow closure of the vessel in a relatively shortamount of time without imposing excessive injury to the tissue tract orvessel.

Another issue common among many of the prior art devices is the need forthe user to reposition her or his hands one or more times duringplacement and operation of the closure device. Therefore, an actuationmechanism with improved ergonomic design that provides greater controland ease of use would also be desirable.

For the above reasons, it would be desirable to provide improveddevices, systems, and methods for suturing vascular punctures. Suchdevices would have the capability of delivering a pre-tied knot to anincision site. It would be particularly beneficial if these improveddevices provided some or all of the benefits while overcoming one ormore of the disadvantages discussed above.

DESCRIPTION OF THE BACKGROUND ART

U.S. Pat. Nos. 5,700,273, 5,836,956, and 5,846,253 describe a woundclosure apparatus and method in which needles are threaded with sutureinside a blood vessel. U.S. Pat. No. 5,496,332 describes a wound closureapparatus and method for its use, while U.S. Pat. No. 5,364,408describes an endoscopic suture system.

U.S. Pat. No. 5,374,275 describes a surgical suturing device and methodof use, while U.S. Pat. No. 5,417,699 describes a device and method forthe percutaneous suturing of a vascular puncture site. An instrument forclosing trocar puncture wounds is described in U.S. Pat. No. 5,470,338,and a related device is described in U.S. Pat. No. 5,527,321, U.S. Pat.No. 5,507,757 also describes a method of closing puncture wounds.

SUMMARY OF THE INVENTION

The present invention provides improved devices, systems, and methodsfor suturing of body lumens. The device often allows the suturing ofvascular puncture sites located at the distal end of a percutaneoustissue tract with greater ease, in less time, and with less patienttrauma than known systems. These improvements are generally providedthrough the use of shafts having smaller cross-sections than priorsuturing systems. In the exemplary embodiment, an elongate articulatedfoot near a distal end of a shaft is inserted through the penetrationand actuated so that the foot extends along the lumenal axis. The footcarries suture attachment cuffs, and can be drawn proximally up againstthe endothelial surface of the blood vessel. Needles are advanced fromthe shaft, through the vessel wall beyond the penetration, and intoengagement with the needle cuffs. The cross-section of the shaft withinthe tissue tract can be minimized by laterally deflecting the needlesbefore they leave the shaft, while tapered depressions within the footcan help guide the advancing needles into engagement with the cuffs. Thecuffs positively engage and capture or trap the needles so that thecuffs can be withdrawn proximally along the needle paths through thetissue tract to form a loop of suture across the puncture without havingto thread the needles directly with the suture inside the blood vessel.The suture loop may be drawn distally from the shaft, proximally fromwithin the blood vessel, or laterally down one of the needle paths,across the puncture, and out the opposing path. Regardless, thearticulating foot may be realigned with the shaft and withdrawnproximally through the tissue tract in a small profile configuration.The use of an articulatable foot in combination with lateral deflectionof the needles can avoid dilation of the tissue tract, as was oftennecessary using known puncture closure systems.

In a first aspect, the invention provides a method for suturing apuncture through a vessel wall of a blood vessel. The puncture isdisposed within a tissue tract of a patient body, and the methodcomprises attaching a flexible filament to a first fitting. The firstfitting is inserted through the tissue tract and positioned adjacent thevessel wall, and a needle path is formed by advancing a first needlethrough the vessel wall. The needle is coupled with the first fitting,and the first needle, the first fitting, and at least a portion of thefilament are withdrawn through the vessel wall along the needle path.

First and second fittings will often be coupled to the flexiblefilament, and will generally be positioned so that the puncture isdisposed therebetween. The flexible filament will often comprise asuture extending between the first and second fittings, with eachfitting being drawn proximally by an associated needle to form thesuture loop. Alternatively, at least one of the needles may include adetachable tip and may advance a suture distally along the needle pathas the needle penetrates through the vessel wall. The flexible filamentcan again couple the first and second fittings, here allowing bothfittings to be withdrawn along a single needle path so that the sutureadvances down along the first needle path, laterally across thepuncture, and then out the other needle path.

Positioning of the fittings is generally effected by articulating anelongate foot within the blood vessel so that the foot extends along thevessel axis. A confirmation lumen may extend along a shaft supportingthe foot to ensure that the foot is positioned within the vessel priorto articulation. Once the foot is properly articulated, it can be drawnproximally to firmly engage the endothelial layer of the vessel. Thefoot will preferably include tapering depressions which direct theadvancing needle toward the fitting, and the suture or other flexiblefilament adjacent the fittings will often be releasably restrainedwithin a narrow slot extending from the depression. The suture or otherflexible filament and its associated slot will preferably be arranged toavoid entanglement of the advancing needle in the suture, and to ensurethat the fitting and suture can be withdrawn proximally as the needle isretracted. An atraumatic, flexible monorail guidebody may extend fromthe shaft and/or the articulatable foot to facilitate alignment of thefoot with the vessel, and also to help provide hemostasis while the knotis tied. A wide variety of foot articulation mechanisms may be provided,with deployment preferably being effected when the foot is disposedentirely within the vessel and using an actuator and foot motion thatavoid dilation of the puncture.

In another aspect, the invention provides a method for suturing anopening in a tissue. The method comprises inserting a distal end of aprobe through the opening, the probe defining a probe axis. An elongatedfoot of the probe is articulated so that first and second ends of thefoot extend laterally with the opening aligned therebetween. A firstneedle path is formed from the probe, through the tissue, and to thefirst end of the foot. A second needle path is formed from the probe,through the tissue, and to the second end of the foot. Suture isadvanced along the first and second needle paths to position a sutureloop across the opening.

In another aspect, the invention provides a method for suturing a bloodvessel. The vessel has a vessel wall, and the method comprises advancinga shaft toward the vessel wall. The shaft has an axis and a plurality ofneedle guides. A foot is deployed adjacent the vessel wall so that thefoot extends laterally from the shaft. A plurality of needles areadvanced from the needle guides of the shaft to the foot to form needlepaths through the vessel wall. The needle guides deflect the needleslaterally so that a needle path width between the needles is greaterthan a cross-sectional dimension of the shaft. Suture is advanced alongthe needle paths to position at least one suture loop across thepuncture.

In yet another method of the present invention, a blood vessel issutured through a tissue tract of a patient body. The vessel has avessel wall, and the method comprises inserting a distal end of a probethrough the puncture and into the blood vessel. A first end of thesuture is advanced from the probe within the tissue tract, through thevessel wall, and into the vessel. The first end of the suture iswithdrawn from the vessel through the vessel wall, and through a bightof the suture to form a loop of suture across the puncture. The firstend of the suture and a second end of the suture adjacent the bight aretensioned to detach the bight from the probe and form a knot affixingthe loop of suture across the puncture. Advantageously, the bight ofsuture may be pre-tied before the probe is inserted into the tissuetract, the bight optionally being releasably attached to the probe.

In a device aspect, the invention provides a system for suturing a bloodvessel. The vessel has a vessel wall, and the system comprises a needlehaving a proximal end and a distal end suitable for forming a needlepath through the vessel wall. The needle has a recessed engagementsurface adjacent the distal end. The system further comprises a flexiblefilament and a fitting attached to the filament. The fitting has anopening and a tab extending into the opening, the tab securinglyengaging the engagement surface when the needle advances through thevessel wall and into the opening, so that the fitting and at least aportion of the filament can be withdrawn proximally along the needlepath by the needle.

In a further device aspect, the invention provides a system for suturinga puncture of a blood vessel within a tissue tract. The vessel has avessel wall and defines an axis, and the system comprises a shaft havinga proximal handle and a distal end suitable for insertion along thetissue tract and into the vessel through the puncture. A foot is mountednear the distal end of the shaft. The foot has plurality of needlereceptacles extendable laterally from the shaft. A flexible filamentextends between the receptacles of the foot. A plurality of needles areadvanceable distally and laterally from the shaft, through the vesselwall outside the puncture, and to the receptacles of the foot.

In yet another device aspect, the invention provides a system forsuturing a puncture of a blood vessel within a tissue tract. The vesselhas a vessel wall, and the system comprises a shaft having a proximalhandle and a distal end suitable for insertion along the tissue tractand into the vessel through the puncture. A foot is mounted near thedistal end of the shaft. The foot has a first needle receptacle and isarticulatable from a small profile configuration to a large profileconfiguration by actuation of the handle. A first fitting is removablymounted adjacent the first needle receptacle. A filament is coupled tothe first fitting. A first needle is advanceable from the shaft to thefirst needle receptacle on the articulated foot. The first fittingsecurely engages the first needle so that the secured first fitting andat least a portion of the filament can be drawn through the vessel wallby the first needle.

In a still further device aspect, the invention provides a probe forsuturing an opening in a tissue. The probe comprises a shaft having aproximal end and a distal end and defining an axis therebetween. Theshaft has a size and configuration suitable for insertion through theopening in the tissue. An elongate foot is movably mounted to the shaft.An actuator extends along the shaft distally to the foot. Movement ofthe actuator slides the foot axially and pivots the foot from a lowprofile configuration to a deployed configuration extending laterallyfrom the shaft. A suture is supported by the foot, and a needle isadvanceable from the shaft, through the tissue, and to the deployedfoot.

In another aspect, the invention provides a suturing device having afirst penetrator and a second penetrator for suturing an incision. Thefirst penetrator is configured to form a first penetration about aperiphery of the incision. The first penetrator also carries a pre-tiedknot disposed about a periphery of the first penetrator for delivery tothe incision. The second penetrator is configured to form a secondpenetration about the periphery of the incision. The second penetratoralso includes suture disposed thereon that is drawn by the firstpenetrator through the first penetration and through the pre-tied knotduring retraction of the first and second penetrators from around theperiphery of the incision. The first penetrator draws the suture throughthe first penetration via a connection between the first penetrator andthe suture. Moreover, as the first penetrator draws the suture, thesuture delivers the pre-tied knot to the incision for closure of theincision.

In another aspect, the invention provides a suturing device for suturingan incision formed in an artery. The suturing device includes a firstpenetrator, a second penetrator and a receiver. The first penetrator,which forms a first penetration about a periphery of the incision,includes a pre-tied knot disposed about the first penetrator. The secondpenetrator, which forms a second penetration about the periphery of theincision, has suture disposed thereon, which retracts through the firstpenetration. The suture retracts through the first penetration into thepre-tied knot during retraction of both the first penetrator and thesecond penetrator from around the periphery of the incision. Inaddition, during retraction, the suture delivers the pre-tied knot tothe incision for suturing of the incision. The suturing device alsoincludes a receiver for receiving both the first penetrator and thesecond penetrator upon penetration formation. The receiver connects thesuture to both the first penetrator and the second penetrator and allowsretraction of the suture through the first penetration as the firstpenetrator and the second penetrator retract.

In another aspect, the invention provides a suturing device for suturingan opening of an artery of a patient during a surgical procedure. Thesuturing device includes a first penetrator, a second penetrator and afoot. The first penetrator is disposed about a periphery of the suturingdevice and the second penetrator is located opposite the firstpenetrator on the suturing device. The first penetrator includes apre-tied knot configured to receive suture releasably engaged with thesecond penetrator during suturing of the opening of the artery. Thefoot, which is movably coupled to the suturing device distal to thefirst penetrator and the second penetrator, includes a first cuff and asecond cuff. The first cuff and the second cuff, which couple to oneanother via a link, receive the first penetrator and a detachable end ofthe second penetrator respectively. The first and second penetratorspenetrate the artery at a proximal end of the suturing device and couplewith the first cuff and the second cuff upon penetration of the artery.The first and second penetrators couple with the first cuff and secondcuff such that during retraction of the first penetrator and the secondpenetrator from the artery, the suture delivers the pre-tied knot to theincision for closure of the incision.

In various aspects and embodiments of the invention described herein, apre-tied knot of suture is also included. The pre-tied knot mayinitially be positioned wrapped around an exterior surface of thedevice. Specifically, a length of suture having opposite ends and abight of suture therebetween is provided with the bight being disposedaround an exterior surface of the device.

In other aspects and embodiments described herein, a suture cuttingblade is positioned on the device. The suture cutting blade provides aconvenient cutting edge across which the suture can be drawn to severthe suture from the needle.

Another aspect and embodiment described herein is to provide an improvedactivation mechanism for the suturing device, which provides an improvedergonomic design that results in greater control and ease of use for theuser.

Yet another aspect is to provide alignment guides to assist in theplacement and rotational orientation of a suture relative to the vesselopening, to facilitate the use of multiple sutures with differentangular orientations, as necessary, to close vessel punctures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective of a percutaneous blood vessel closure deviceaccording to the principles of the present invention.

FIGS. 2A-C illustrate actuation of a foot and advancement of needlesfrom a shaft to the articulated foot in a probe similar to the probe ofFIG. 1.

FIG. 3A is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a parked position prior to deployment.

FIG. 3B is a detailed view showing the foot of the vessel closure deviceof FIG. 1 in a deployed position.

FIGS. 4 and 4A are perspective views illustrating a suture attachmentcuff and an associated barbed needle for use in the vessel closuredevice of FIG. 1.

FIG. 5 is a cross-sectional view showing the barbed needles securinglyengaging the suture cuffs of the deployed foot.

FIGS. 6A-C illustrate one embodiment of a deployable foot, in which thefoot slides and pivots when drawn proximally by a tension member.

FIG. 7 illustrates the suture cuff positioned within a needlereceptacle, and also shows how the suture is releasably secured within aslot extending radially from the needle receptacle.

FIGS. 8A-G illustrate a method for use of a suture system to effecthemostasis of a blood vessel puncture through a tissue tract.

FIG. 9 is a perspective view of a suturing device including a suturecutting blade positioned on the device.

FIG. 10 is a perspective view of another embodiment of a vessel closuredevice.

FIGS. 10A and 10B are top and side views, respectively, of anotherembodiment of a vessel closure device.

FIGS. 11A-D illustrate various steps in the operation of the vesselclosure device.

FIG. 12 is a plan view of the vessel closure device with the top of thehousing removed, showing the internal components located within theproximal housing of the device.

FIG. 13 is a detail view of the distal end of the housing, illustratingmultiple alignment markings.

FIGS. 14A-C are schematic representations of different angularorientations that can be achieved through the use of the multiplealignment markings of the device.

DETAILED DESCRIPTION

Several embodiments of suturing device that delivers a pre-tied knot toa puncture or incision in a wall of tissue is disclosed. Various aspectsof such a device include a length of suture having a bight between firstand second ends of the suture. The bight includes one or more loops ofsuture that form a pre-tied knot when one or more ends of the suture areadvanced through the bight. The bight of suture may be prearranged inany of several configurations on the device.

Referring now to FIG. 1, a vessel closure device 10 generally has ashaft 12 having a proximal end 14 and a distal end 16. A proximalhousing 18 supports a needle actuation handle 20. A flexible, atraumaticmonorail guidebody 22 extends distally of distal end 16 of shaft 12.

As can be seen with reference to FIGS. 2A through C, a foot 24 isarticulatably mounted near the distal end of shaft 12. Foot 24 movesbetween a low profile configuration, in which the foot is substantiallyaligned along an axis of shaft 12 (as illustrated in FIG. 1), to adeployed position, in which the foot extends laterally from the shaft,upon actuation of a foot actuation handle 26 disposed on proximalhousing 18.

FIGS. 2A through C illustrate the structure and actuation of foot 24 ofan embodiment of probe 10, and also show how needles 38 can be advanceddistally from shaft 12 to the foot by depressing needle actuation handle20 (see FIG. 2C).

Actuation of foot 24 is illustrated more clearly in FIGS. 3A and B. Inthe parked position illustrated in FIG. 3A, foot 24 extendssubstantially along axis 28 of shaft 12. Note that the axis of the shaftneed not be straight, as the shaft may curve somewhat, particularlyadjacent the foot. In the exemplary embodiment, foot 24 is substantiallydisposed within a foot receptacle 30 of shaft 12 to minimize thecross-section of the device adjacent the foot prior to deployment.Advantageously, prior to deployment of the foot, device 10 can have across-section adjacent foot 24 of about 7 Fr or less, ideally having across-section of about 6 Fr or less for the entire device distally ofthe proximal end 14 of shaft 12.

Actuation of foot handle 26 slides a foot actuation wire 32 proximally,pulling foot 24 from a parked position to the deployed positionillustrated in FIG. 3B. Once deployed, a first end 24 a and a second end24 b of foot 24 extend laterally from the shaft. Suture 34 herecomprises a continuous filament with ends disposed in needle receptaclesadjacent each end of the foot. An intermediate portion of suture 34 mayextend proximally along a suture lumen of shaft 12 to and/or beyondproximal housing 18. Alternatively, the length of suture between theends may extend distally within flexible guidebody 22, preferably in adedicated lumen (separate from the monorail guidewire lumen). In stillfurther alternatives described below, a short length of suture or someother flexible filament may extend substantially directly between theneedle receptacles.

Shaft 12 also includes a foot position verification lumen that extendsdistally from a position verification port 36 to a position indicator athousing 18. When the foot is properly positioned within the bloodvessel, blood pressure will cause blood to flow proximally through theindicator lumen to the indicator. The indicator may optionally comprisea blood exit port, a clear receptacle in which blood is visible, or thelike. In the exemplary embodiment, the indicator of handle 18 comprisesa length of clear tubing extending from housing 18 (not shown) in whichthe blood is clearly visible. It should be understood that a widevariety of alternative position verifications sensors might be used,including electrical pressure sensors, electrolytic fluid detectors, orthe like.

The structures used in positioning a loop of suture across the puncturecan be understood with reference to FIGS. 4, 4A, and 5. In generalterms, needles 38 extend from shaft 12 into secured engagement withfittings 40 attached to sutures 34. More specifically, needles 38include a barbed end 42 defining a recessed engagement surface 44.Fittings 40 are roughly cylindrical structures having an axial channel46 which receives barbed end 44 of needle 38 therein. A first slot iscut in fitting 44 to define at least one tab 48. Tabs 48 can beresiliently biased inward into channel 46. As needle 38 advances intofitting 40, barbed end 42 resiliently displaces tab 48 clear of channel46 to allow the barbed end to pass axially into the fitting. Once barbedend 42 is disposed axially beyond tab 48, the tab resiliently flexesback into the channel, capturing needle 38 by engagement between the taband recessed surface 44. As each tab can hold the fitting in place onthe needle, the use of more than one tab increases the reliability ofthe system. Ideally, three tabs are provided, as illustrated in FIG. 4A.

To facilitate attachment of fitting 40 to suture 34, a second slot cutin the tubular fitting structure defines a suture attachment collar 50.Optionally, collar 50 may be crimped about suture 34 to mechanicallyaffix the suture to fitting 40. In addition and/or instead of mechanicalcrimping, suture 34 may be bonded to fitting 40 using an adhesive, heat,fasteners, knots, or the like.

Fitting 40 is quite small in size, and is generally configured tofacilitate withdrawing the fitting (and the attached suture) along withneedle 38 axially through the vessel wall along the needle path. Needle38 will generally have a cross-sectional width of between about 0.010inches and 0.020 inches. Barb 42 will extend laterally to define anengagement surface 44 having a protruding length of between about 0.002inches and 0.005 inches. Fitting 40 will preferably have across-sectional size roughly corresponding to or only slightly largerthan needle 38. Fitting 40 will typically have an outer lateral width ofbetween about 0.014 inches and 0.025 inches, and an axial length ofbetween about 0.035 inches and 0.050 inches. Channel 46 will be sized toreceive at least a portion of needle 38, and will generally have a widthof between about 0.010 inches and 0.020 inches. Suture 34 willpreferably extend axially opposite the open end of channel 46 tominimize drag when the suture is drawn proximally along the needle path.In the exemplary embodiment, needle 38 has a diameter of about 0.020inches, while the fitting comprises a tube having an outer diameter ofabout 0.020 inches, an inner diameter of about 0.016 inches, and anoverall length of about 0.047 inches. The fitting will typicallycomprise a resilient material, preferably comprising a metal, and in theexemplary embodiment, comprising stainless steel.

Needles 38 typically have a length of between about 5.0 inches and 6.0inches, and will preferably be sufficiently stiff to be advanced incompression through the vessel wall (and adjacent tissues) for up to 0.5inches when supported in cantilever. Nonetheless, the needles willideally be flexible enough to be laterally deflected within shaft 12, ascan be understood with reference to FIG. 5. Needles 38 generallycomprise a high strength metal, ideally comprising stainless steel.Fittings 40 will also preferably comprise a flexible material to allowtab 48 to flex out of the way of barbed end 42, and to resilientlyrebound and engage recessed surface 44. In the exemplary embodiment,barbed end 42 has a diameter of about 0.015 inches, with the diameter ofthe needle decreasing to about 0.008 inches proximally of the barb todefine the recessed engagement surface.

As was generally described above, foot 24 includes needle receptacles 52adjacent the ends of the foot. A fitting 40 (with an associated end ofsuture 34) is disposed within each needle receptacle, and a surface ofthe receptacle tapers proximally and outwardly so as to guide theadvancing needles 38 into engagement with fittings 40 when foot 24 is inthe deployed position. As fittings 40 (and associated portions of suture34) are releasably supported in the foot, needles 38 can be withdrawnproximally so as to draw the fittings and suture ends from the footproximally into (and optionally through) shaft 12. The needlereceptacles of the exemplary embodiment taper outward at an anglebetween 20 and 35 degrees from the centerline of fitting 40, and thefitting is held in a recess having a diameter of about 0.0230 inches anda length of about 0.042 inches. A lateral opening or window through theside of foot to the fitting recess may be provided to facilitate needleand/or cuff positioning during assembly of the probe, and a protrudingcollar near the proximal end of the fitting recess may help keep thefitting in position.

A wide variety of foot actuation mechanisms might be used within thescope of the present invention.

FIG. 5 also illustrates the lateral deflection of needles 38 by needleguides 54 of shaft 12. This lateral deflection of the needles allows theuse of a small diameter shaft, while still encompassing sufficienttissue within the suture loop on opposite sides of the puncture toeffect hemostasis when the suture looped is tightened and secured. Inthe exemplary embodiment, shaft 12 comprises an outer casing of abiocompatible material such as stainless steel, carbon fiber, nylon,another suitable polymer, or the like. Needle guides 54 may be definedat least in part as lumens formed within the casing of a polymericmaterial such as nylon or the like. In some embodiments, shaft 12 maycomprise a carbon fiber filled nylon, or carbon fiber filled with analternative material.

One example of a suitable structure and articulation motion for foot 24is illustrated in FIGS. 6A and B. Foot actuation wire 32 (see FIG. 3A)rides in a lumen of shaft 12, and draws foot 24 from a parked position(shown in FIG. 6A) to a deployed position (shown in FIG. 6B) through acombination of sliding and pivoting of the foot. The foot remainssupported throughout its range of motion by arms disposed laterally oneither side of the foot, the arms defining (at least in part) footreceptacle 30. Once foot 24 is deployed, needle receptacles 52 and/orthe fittings disposed therein will preferably define a lateral suturingwidth 56 in a range from about 0.260 inches to about 0.300 inches. Foot24 may be machined or cast from a polymer or metal, but will preferablycomprise a polymer such as carbon fiber or glass-filled nylon orsuitable reinforcement material. In some cases, foot 24 may be molded astwo separate halves which can subsequently be affixed together. Needles38 advance from the fixed needle guides 54, and are laterally directedinto fittings 40 by receptacles 52, as illustrated in FIG. 6C. Ingeneral, a shape memory alloy such as Nitinol® in its superelasticregime provides a particularly advantageous actuator wire formanipulating foot 24. A wide variety of foot designs and foot actuationmechanisms can be used within the scope of the invention.

Referring now to FIG. 7, fittings 40 and suture 34 will be withdrawnproximally by the needles from needle receptacles 52. To releasablysupport fittings 40 and suture 34 and avoid entanglement of the suturein the needles, suture 34 is fittingly received within a slot 58 whichextends laterally from needle receptacles 52. As the needles pull thefitting axially from needle receptacles 52, suture 34 is pulled fromslot 58 and free from foot 24. Bending of the suture proximally withinthe suture slot can also locally increase the suture width, so that theinteraction between the bent suture and the slot can help hold thefitting in the recess.

The operation and use of probe 10 can be further understood withreference to FIGS. 8A-G. After accessing a blood vessel V (often usingthe Seldinger technique), a guidewire GW is left extending into skin Sand down through tissue T along tissue tract TT. Guidewire GW entersvessel V through a puncture P in vessel wall W, and extends along thevessel throughout many endovascular procedures. As illustrated in FIG.8A, distal guidebody 22 is advanced over the guidewire GW in a monorailfashion, so that the guidewire helps to direct the probe along thetissue tract TT and into the vessel through puncture P. FIG. 8B showsthat when sensor 36 is disposed within the vessel, blood can flow fromthe sensor port and through a lumen in shaft 12 to the proximal handleto notify the operator that foot 24 has been advanced far enough fordeployment.

Deployment of the foot is effected by actuation of the foot deploymenthandle 26, as described and illustrated above with reference to FIGS. 2,2B and 3B. As described above, guidebody 22 helps to align the probewith the axis of vessel V. Guidebody 22 may be set at an angle and/oroffset relative to shaft 12 as appropriate to aid in alignment with aparticular vessel access technique. As shown in FIG. 8C, the deployedfoot 24 extends laterally from the shaft, so that foot 24 adjacentreceptacles 52 can be drawn up against vessel wall W by gently pullingshaft 12. Hence, the foot helps to accurately position the needle guides54 at a distance from the vessel wall.

Referring now to FIG. 8D, once foot 24 is properly positioned againstthe inner surface of the vessel wall, flexible needles 38 can beadvanced through the vessel wall by depressing needle actuator handle20, thereby advancing needle actuator handle 20 and flexible needles 38in a distal direction. As they are advanced distally, flexible needles38 are deflected laterally by needle guides 54 toward receptacles 52 ofthe deployed foot. As a result, the needles advance in cantilever bothdistally and laterally when needle actuation handle 20 is pressed (seeFIG. 2C), and the tapering surfaces of receptacles 52 help to push theneedles back into alignment with the fittings so as to overcome anyunintended deflection of the needles by tissue T or vessel wall W. Thisensures that needles 38 securingly engage fittings 40 within receptacles52 (see FIGS. 5, 6C and 7), thereby coupling the ends of suture 34 tothe needles. While suture 34 is here illustrated running along the sideof shaft 12 outside foot receptacle 30 to a lumen within guidebody 22,it should be understood that the suture loop might instead extendproximally in a lumen of shaft 12, might be routed through the footand/or foot receptacle, and/or might be stored in a spool adjacent foot24. Regardless, suture 34 should able to pull free of the probe betweenits ends to form a continuous loop across puncture P.

Referring now to FIGS. 8E and F, once the needles 38 have been fullyadvanced into, and engage, fittings 40, the needles 38, with fittings 40and suture 34 now attached to the ends of needles 38, can then bewithdrawn proximally by pulling on needle actuation handle 20 (FIG. 2C)in a proximal direction. Fittings 40 and the ends of suture 34 are drawnproximally through the vessel wall W along the needle paths formed byneedles 38. Optionally, the needles may be withdrawn proximally out ofthe tissue tract and clear of shaft 12, or they may remain coupled tothe shaft within needle guides 54.

Once the needles 38 are withdrawn into the needle guides, the footactuator 26 is moved to store foot 24 along shaft 12, and the shaft canthen be pulled proximally from the tissue tract. Guidebody 22, which maycomprise a soft, compliant polymer, may temporarily extend at leastpartially into tissue tract TT and through puncture P to help reduce theloss of blood until the loop is secured.

Now referring to FIG. 8G, once shaft 12 has been withdrawn sufficientlyto expose needle guides 54, the ends of the suture loop can be graspedby the operator. Tying of a knot in suture 34 can then proceed in aconventional manner. The use of a clinch knot may facilitate gradualtightening of the knot while removing guidebody 22, although a widevariety of knot and knot advancing techniques might be used.

As shown in FIG. 9, the suturing device 10 may also include a blade 60positioned on the device to provide a convenient cutting edge to severthe suture to detach the suture from the needle or needles. FIG. 9 showsa suturing device 10 of the type having an articulated foot describedherein. The suturing device 10 is particularly useful for suturing anopening in a femoral artery of a patient after the completion of apercutaneous transluminal catherization procedure, or the like. Suturingdevice 10 is an example of the type of device that may include a blade60 positioned on the device. For convenience of description, only thissuturing device embodiment will be described with respect to the suturecutting blade feature. It is to be understood, however, that anysuturing device employing a needle and suture to close an opening in atissue wall may incorporate the suture cutting blade feature describedmore fully below.

The suturing device 10 shown in FIG. 9 includes a housing 18. One ormore needles 38 are operatively associated with the device. The needles38 are movable with respect to the housing 18. The needles 38 are shownin FIG. 9 withdrawn from the housing 18. In this exemplary embodiment,only one of the two needles 38 are shown attached to a length of suture34. In other embodiments, both needles may be attached to the suture 34.Alternatively, the device may only include one needle.

A suture cutting blade 60 is positioned on the device 10 such that whenthe needle 38 and attached suture 34 are withdrawn from the device, thesuture 34 can be drawn across the blade 60 to sever the suture. FIG. 9shows the position of the needle and suture with respect to the housing18 and the blade 60 just prior to the suture being cut to detach theneedle 38 from the length of suture. As can be seen in FIG. 14, aportion of the suture may remain attached to the needle 38 due to thesuture being cut at a short distance from the end of the needle. Thelength of suture that is used to close the opening in the tissue will bedetached from the needle or needles. Once the needle 38 is cut away fromthe length of suture that has been withdrawn from the proximal end 22 ofthe housing 18, the device 10 can be removed from the patient's anatomywithout interference from the needle actuation handle 20.

Additional details regarding such articulating suturing devices andmethods are provided in: U.S. patent application Ser. No. 15/090,150,filed Apr. 4, 2016, and entitled “Articulating Suturing Device andMethod;” U.S. patent application Ser. No. 14/195,308, filed Mar. 3,2014, and entitled “Articulating Suturing Device and Method;” U.S.patent application Ser. No. 12/334,077, filed Dec. 12, 2008, andentitled “Articulating Suturing Device and Method,” now U.S. Pat. No.8,663,248; U.S. patent application Ser. No. 10/660,288, filed Sep. 11,2003, and entitled “Articulating Suturing Device and Method,” now U.S.Pat. No. 8,137,364; U.S. patent application Ser. No. 10/652,182, filedAug. 29, 2003, and entitled “Articulating Suturing Device and Method,”now U.S. Pat. No. 7,235,087; U.S. patent application Ser. No.10/152,272, filed May 20, 2002, and entitled “Articulating SuturingDevice and Method,” now U.S. Pat. No. 6,964,668; U.S. patent applicationSer. No. 09/651,344, filed Aug. 29, 2000, and entitled “ArticulatingSuturing Device and Method,” now U.S. Pat. No. 7,001,400; and U.S.patent application Ser. No. 09/262,402, filed on Mar. 4, 1999, andentitled “Articulating Suturing Device and Method,” now U.S. Pat. No.6,136,010, each of which is hereby incorporated by reference in itsentirety.

One issue associated with the embodiments described above is that,during use of the device 10, a user (surgeon) must reposition her or hishands several times during use. For example, it is common for thesurgeon to hold the proximal end of housing 18 with one hand and to holdand stabilize the distal end of housing 18 with the other hand whileadvancing the device over the guidewire and inserting the device throughthe tissue tract. Once device 10 is inserted far enough into the vesselthat blood flows into the device 10 and out of the blood sensor port(thereby indicating that device 10 is properly positioned within thevessel so as to allow foot 24 to be deployed), then the surgeon mustrelease the distal end of housing 18, reposition her or his hand todeploy foot 24 by manipulating foot actuation handle 26. Then, it iscommon for the surgeon to reposition her or his hand to again stabilizethe distal end of housing 18 (i) as the device is drawn proximally toposition foot 24 against the inner surface of the vessel wall, (ii) asneedles 38 are advanced distally to engage fittings 40, and (iii) asneedles 38, fittings 40 and suture 34 are withdrawn proximally from thetissue tract. Finally, the surgeon must, once again, reposition her orhis hand from the distal end of housing 18 to rotate foot actuationhandle 26 in the other direction to the return foot 24 to its parked orcollapsed position to permit removal of device 10. It would, therefore,be an improvement to provide a vessel closure device of the typedescribed herein and that provides an improved ergonomic design thatallows placement, actuation and removal without requiring the user toreposition her or his hands multiple times during the procedure.

FIGS. 10 through 12 illustrate another embodiment of an articulatingsuture device 110 that provides additional ease of use. Suture device110 is similar in many respects to the embodiments illustrated anddescribed above, and corresponding parts and features are labeled withcorrespondingly similar reference numerals.

One primary difference between the embodiment shown in FIGS. 1 through14 and the embodiment of FIGS. 10 through 12 is the foot actuationhandle 26. In FIGS. 1 through 14, foot actuation handle 26 is a leverthat rotates about an axis that is oriented transverse with thelongitudinal axis of device 10 and housing 18. As mentioned above, thisdesign requires the surgeon to reposition her or his hands multipletimes during the various steps of the procedure in order to deploy andretract the foot. As illustrated in FIGS. 10 through 12, foot actuationhandle 126 consists of a pair of handles 126 a and 126 b that extendtransversely from each side of housing 118 and move in a lineardirection parallel with the longitudinal axis of housing 118. Asillustrated, handles 126 a and 126 b can have a “trigger” configuration.

Another difference is in the operation of device 110. In particular, theembodiment makes it possible to place, actuate and remove device 110 ina substantially continuous series of actions without the need for thesurgeon to reposition her or his hands in the process. As described ingreater detail below, the surgeon may grasp the proximal end of housing118 in one hand, by positioning her or his thumb on the proximal end ofneedle actuation handle 120 and positioning her or his index and middlefingers on foot actuation handles 126 a and 126 b (see FIG. 11A). Inaddition, the surgeon can hold and stabilize the distal end of housing118 with the other hand. Once device 110 is properly positioned withinthe vessel, foot 124 is deployed by drawing foot actuation handles 126 aand 126 b in a proximal direction (see FIG. 11B). This is done simply bythe user applying pressure between the proximal end of needle actuationhandle 120 and foot actuation handles 126 a and 126 b, thereby drawingfoot actuation handles 126 a and 126 b in a proximal direction relativeto housing 118 and needle actuation handle 120. Once foot 124 is fullydeployed, foot actuation handles 126 a and 126 b engage slots formed inthe side of the housing to temporarily lock handles 126 a and 126 b intoplace relative to housing 118. Then, needles 138 can be deployed andadvanced distally to engage foot 126 by simply applying additionalpressure to needle actuation handle 120, thereby moving needle actuationhandle 120 (and thus needles 138) in a distal direction relative tohousing 118 (see FIG. 11C). Once needles 138 are fully advanced andengage fittings 140, the surgeon simply pulls needle actuation handle120 in a proximal direction relative to housing 118 to draw needles 138,fittings 140 and suture 134 through the vessel wall and back into needleguides 154 (see FIG. 11D). Finally, as needle actuation handle 120 iswithdrawn in the proximal direction, it automatically releases footactuation handles 126 a and 126 b from their locked position, so thatfoot actuation handles 126 a and 126 b are free to return theiroriginal, starting position, thereby returning foot 124 to its parked orcollapsed position (see FIG. 11D). And, all of the foregoing steps canbe performed by the surgeon without having to reposition her or hishands during the entire procedure.

Referring to FIG. 12, the various components of this embodiment, andtheir interactions one with another, will be discussed in additionaldetail. Housing 118 has a bottom portion 118 a and a top portion 118 b.In FIG. 12, the top portion 118 b has been removed and is not shown, soas to reveal various components housed within housing 118. Situatedtoward the distal end of housing 118 is a tensioner assembly 162 thatapplies a small, predetermined amount of tension to the foot actuationwire 132 when foot 124 is in a deployed position. Tensioner assembly 162can include a sled 163 and a tensioner block 164. Sled 163 can have arectangular portion 165, with a tensioner well 166 formed therein, and apair of control arms 167 a and 167 b that extend from the proximal endof rectangular portion 165 and extend in a proximal direction. Controlarms 167 a and 167 b can be coupled to foot actuation handle 126 in amanner described below. Tensioner block 164 and a bias spring 168 can bepositioned within tensioner well 166. Tensioner block 164 can include awire lumen 169 that extends longitudinally along the length of tensionerblock 164 and is configured to receive a portion of the proximal end offoot actuation wire 132 in lumen 169. In this embodiment, foot actuationwire 132 is bonded to a portion of tensioner block 164 with a suitablebonding agent, glue or liquid cement. When the foot 124 is deployed,spring 168 is compressed a small amount between tensioner block 164 andthe distal wall of tensioner well 166 to provide and maintain a smallamount of tension on foot actuation wire 132 and thereby bias foot 124to its deployed position.

Situated toward the proximal end of housing 118 is a connector assembly172. Connector assembly 172 can include a connector 173, a follower 174and a connector spring 175. Follower 174 can terminate at its distal endin a ball 176. Connector assembly 172 connects needle actuation handle120 to the proximal ends of needles 138 at ball 176. As shown in FIG.10, connector spring 175 is positioned between needle actuation handle120 and the proximal end of housing 118 and biases needle actuationhandle 120 towards its proximal, undeployed position. As furtherillustrated in FIG. 10, the housing can be provided with a pair ofprojections or fingers 196 a and 196 b that extend vertically frombottom housing 118 a and engage opposite sides of ball 176 and onopposite sides of needles 138. Alternatively, projections 196 could alsoextend downward from top housing 118 b, or from both bottom and tophousings 118 a and 118 b. In any event, projections 196 a and 196 binitially prevent movement of needle actuation handle 120 in eitherdirection by constraining ball 176 between projections 196 a and 196 b.However, projections 196 a and 196 b can be designed and configured tohave a certain level of resilience, so that the application of apredetermined amount force to needle actuation handle 120 is required toand will cause projections 196 a and/or 196 b to either break or to flexto a sufficient degree to allow ball 176 to pass through, therebyallowing needle actuation handle 120 to move in a distal direction todeploy needles 138 and/or to move in a proximal direction to withdrawneedles 138.

Situated between tensioner assembly 162 and connector assembly 172 isfoot actuation handle 126, which forms a linkage between tensionerassembly 162 and connector assembly 172. As mentioned previously, footactuation handle 126 can include a pair of handles 126 a and 126 bpositioned on and extending laterally from oppositing sides of housing118. Foot actuation handle 126 can also include a pair of arms 176 a and176 b that extend along opposing sides of the exterior of housing 118.Arms 176 a and 178 b are connected at their proximal ends to handles 126a and 126 b, respectively. The other ends of arms 176 a and 176 b extendthrough slots formed in opposing sides of housing 118 and connect to acentral hub 177. Central hub 177 has a lumen 178 extending through thecenter, through which needles 138 and follower 174 can pass. Central hub177 can also have a pair of recesses 179 a and 179 b that are configuredto receive the proximal ends of control arms 167 a and 167 b,respectively, of sled 163. With control arms 167 a and 167 b positionedwithin recesses 179 a and 179 b, handles 126 a and 126 b and tensionerassembly 162 are coupled together so that they move together in eitheraxial direction. When handles 126 a and 126 b are moved in a proximaldirection, this causes tensioner assembly 162 to also move in a proximaldirection, thereby deploying foot 124 from a parked position to adeployed position. Conversely, when handles 126 a and 126 b move in adistal direction, this causes tensioner assembly 162 to also move in adistal direction, thereby causing foot 124 to move from a deployedposition to a parked position.

Foot actuation handle 126 can also include a pair of lock detents 180 aand 180 b, located at the proximal end and on the inner surface of arms176 a and 176 b, respectively. When foot actuator handle 126 is movedproximally to its deployed position, lock detents 180 a and 180 b engageactuator locking windows 182 a and 182 b, respectively, which are formedon either side of housing 118, temporarily locking foot actuator handle126 (and, thus, foot 124) in the deployed position. Foot actuator handle126 remains locked in the deployed position while needle actuator handle120 is moved in a distal direction, causing needles 138 to engagefittings 140. Then, as needle actuation handle 120, needles 138,fittings 140 and suture 134 are withdrawn in a proximal direction andremoved from the tissue tract, a portion of needle actuation handle 120engages the ends of lock dents 180 a and 180 b, thereby releasing themfrom locking windows 182 a and 182 b and allowing foot actuation handle126 (and foot 124) to return to the parked position. A return spring 190is positioned within housing between a flange 192 formed in bottomhousing 118 a and the proximal end of sled 163. Return spring 190 biasesfoot actuation handle 126 toward its original, distal and parkedposition.

The device 110 also includes a first interlock mechanism 188 thatprevents needle actuation handle 120 and/or connector assembly 178 frommoving relative to the housing, either in a proximal or distaldirection, while foot 124 is in its initial parked position. Once foot124 is moved to its deployed or expanded position, then first interlock188 automatically releases needle actuation handle 120 and connectorassembly 178 to move in a distal direction relative to the housing andthereby advance needles 138 in a distal direction to engage foot 124.Similarly, with foot 124 in its deployed position, first interlock 188also permits needle actuation handle 120 and connector assembly 178 tobe withdrawn in a proximal direction relative to housing 118 and therebywithdraw needles 138, fittings 140 and suture 134 through the vesselwall and through the tissue tract. In one embodiment, first interlockmechanism 188 can include ball 176 and projections 196 a and 196 b,which cooperate in the manner described above to perform thefunctionality of first interlock mechanism 188.

Device 10 also includes a second interlock mechanism 190 that locks footactuation handle 126 in place when it foot actuation handle 126 is movedto its position to deploy foot 124 and to thereby maintain foot 124 inits deployed position while needles 138 are advanced distally to engagefittings 140 and then withdrawn proximally from the vessel wall andtissue tract. As discussed above, once needles 138 have been withdrawnin a proximal direction far enough that the distal ends of needles 138have been completely withdrawn into needle guides 154, then secondinterlock mechanism 190 automatically released foot actuation handle 126to return to its original position, thereby returning foot 124 to itsparked or collapsed position. In one embodiment, second interlockmechanism 190 can include lock detents 180 a and 180 b and actuatorlocking windows 182 a and 182 b, which cooperate in the manner describedabove to perform the functionality of second interlock mechanism 190.

Yet an additional aspect and feature of the invention will now bediscussed with reference to FIGS. 13 and 14. In some situations, such aswhen attempting to close a vessel puncture with a relatively largediameter, it may be desirable to apply multiple sutures across the sameopening, but at different positions and/or orientations. To assist withthe placement of sutures at different angular orientations relative tothe puncture, the vessel closure devices described above can alsoinclude alignment markings positioned on the exterior adjacent thedistal end of the proximal housing. For example, vessel closure devices110 can also include one or more alignment marks, such as alignmentmarks 200 a, 200 b and 200 c, as illustrated in FIG. 13. Alignment marks200 provide a visual reference relative to the relative orientation ofneedles 138. In this particular embodiment, needles 138 a and 138 b arealigned with alignment mark 200 a, such that when device 110 is rotatedand oriented so that alignment mark 200 a is positioned directly on topof handle 118 (i.e., vertically oriented), then the relative position ofneedles 138 a and 138 b would also be substantially vertically orientedrelative to the axis 128 of shaft 112. Thus, when device 110 is rotatedclockwise until alignment mark 200 b is vertically oriented (i.e., ispositioned at the twelve o'clock), then the relative position of needles138 a and 138 b would be oriented at an approximately 60 degree anglerelative to the vertical (oriented in the clockwise direction).Conversely, when device 110 is rotated counter-clockwise until alignmentmark 200 c is vertically oriented (i.e., is positioned at the twelveo'clock), then the relative position of needles 138 a and 138 b would beoriented at an approximately 60 degree angle relative to the vertical,but oriented in the counter-clockwise direction.

Thus, alignment marks 200 provide a visual guide to allow the surgeon toselectively and accurately locate one or more sutures across the vesselpuncture at different angular orientations. In the case of multiplesutures, this would require a separate vessel closure device 110 foreach suture. For example, if two sutures were desired at differentangular positions, a first closure device 110 would be used to place afirst suture across the vessel opening at a first angular orientation asgraphically depicted in FIG. 14A. The first suture would be cut, but nottied, and then the first closure device is removed, leaving theguidewire in place. Then a second suture device 110 would be insertedover the guidewire and properly positioned within the same vesselopening. However, using one of the other the alignment marks, the seconddevice would be positioned at a different angular orientation to placethe second suture across the vessel opening at a second angularorientation (as graphically illustrated in FIG. 14B). Once the seconddevice is removed, then both the first and second sutures could be tied,closing off the vessel puncture site. And, as indicated in FIG. 14C,this process could be extended as needed to provide a third suture.

In operation, a tissue suturing device is used by advancing a needledistally to penetrate the tissue and position a suture through thetissue. In various embodiments described herein, attaching the suture tothe needle is accomplished by moving the needles distally through ahousing of a device to connect to the suture. The suture is positionedthrough the tissue by withdrawing the needle proximally through theproximal end of the housing. Finally, the needle can be separated fromthe suture by drawing the suture across the suture cutting blade tosever the needle from the suture.

The various embodiments of a suturing device described herein can beprovided to position a suture across an opening in a wall of a bloodvessel to close the opening. In a femoral artery closure procedure, forexample, such devices are used to advance the suture and the needlepercutaneously through subcutaneous tissue to a blood vessel accesssite.

The present invention offers surgeons an automated method for deliveringa pre-tied knot to an incision formed in a tissue wall. The presentinvention simplifies the effort associated with a surgeon manuallydelivering a knot to an incision site. Thus, the present inventionreduces the time required to accurately and precisely place a sutureknot in close proximity to an incision formed in a lumen, therebydecreasing both the overall time a patient spends in procedure andrecovery and the costs associated therewith.

While the exemplary embodiments have been described in some detail forclarity of understanding, a wide variety of modifications, adaptations,and changes will be apparent to those of skill in the art. Hence, thescope of the present invention is limited solely by the appended claims.

What is claimed is:
 1. An improved actuation and control mechanismintended for use in a vessel closure device for closing an opening orpuncture in a vessel wall having an elongate shaft having a longitudinalaxis, a housing positioned at the proximal end of the shaft, a flexible,atraumatic monorail guidebody positioned at the distal end of the shaft,a foot articulatably mounted proximate the distal end of the shaft, thefoot being movable between a first, parked position, in which the footis substantially aligned along the axis of the shaft, and a second,deployed position, in which the foot extends laterally away from theshaft, the foot having a first and a second end, the first end and thesecond end each having a needle receptacle with a cuff positionedtherein, a length of suture located within the foot and extendingbetween the cuffs, and a pair of needles located within the shaft thatcan be selectively advanced through the vessel wall adjacent to theopening and into the cuffs located in the needle receptacles in thefirst and second ends of the foot, and that can be selectively withdrawnthereby drawing the suture through the vessel wall adjacent to theopening, the improved actuation and control mechanism for the vesselclosure device comprising: a foot actuation handle operatively coupledto the foot, the foot actuation handle being selectively moveablelinearly along the axis of the device between a distal position wherebythe foot is positioned in its first, parked position, and a proximalposition whereby the foot is positioned in its second, deployedposition, the foot actuation handle comprising a pair of handles thatextend laterally from opposing sides of the housing, and wherein thefoot actuation handle is configured to be grasped and manipulated by apair of fingers of one hand of a user; and a needle actuation handleoperatively coupled to the needles, the needle actuation handle beingselectively movably linearly along the axis of the device between aproximal position wherein the needles are located within the shaft and adistal position wherein the needles are advanced to engage the cuffs,and wherein the needle actuation handle is configured to be engaged andselectively manipulated by a thumb of the same one hand of the user. 2.The vessel closure device of claim 1, wherein the foot is deployed byaxial movement of the foot actuation handle in the proximal directionrelative to the needle actuation handle.
 3. The vessel closure device ofclaim 2, wherein, once the foot is deployed by proximal movement of thefoot actuation handle, the needles are deployed into engagement with thefoot by axial movement of the needle actuation handle in the distaldirection relative to the foot actuation handle.
 4. The vessel closuredevice of claim 1 further comprising a first interlock mechanism thatprevents the needle actuation handle from being advanced from itsproximal position when the foot is positioned in its first, parkedposition, but allows the needle actuation handle to be advanced from itsproximal position to its distal position after the foot is moved to itssecond, deployed position.
 5. The vessel closure device of claim 4,wherein the first interlock mechanism comprises: a ball formed on adistal end of the needle actuation handle; and a pair of projectionsformed on the housing and engaging opposing sides of the ball toconstrain movement of the ball until a predetermined amount of pressureis applied to the needle actuation handle force the ball past theprojection.
 6. The vessel closure device of claim 5, wherein projectionsare flexible and resilient and are configured bend upon application ofthe predetermined amount of pressure applied to the needle actuationhandle to allow movement of the ball in the distal direction.
 7. Thevessel closure device of claim 5, wherein projections are configuredbreak upon application of the predetermined amount of pressure appliedto the needle actuation handle to allow movement of the ball in thedistal direction.
 8. The vessel closure device of claim 1 furthercomprising a second interlock mechanism that temporarily locks the footactuation handle into place when it is moved from its distal position toits proximal position.
 9. The vessel closure device of claim 8 whereinthe second interlock mechanism automatically releases the foot actuationhandle from its proximal position after the needle actuation handle isreturned to its proximal position from its distal position.
 10. Thevessel closure device of claim 9 further comprising a return bias springassociated with the foot actuation handle for biasing the foot actuationhandle toward its distal position.
 11. The vessel closure device ofclaim 10, wherein the second interlock mechanism comprises: a pair oflock detents positioned on an inner surface of the foot actuationhandle; a pair of lock windows formed in opposing sides of the housingand positioned so as to receive the lock detents when the foot actuationhandle is moved to its proximal position and thereby temporarily lockthe foot actuation handle in its proximal position; and a pair offlanges formed on an inner portion of the needle actuation handle, theflanges being configured to engage the lock detents and release the lockdetents from the lock windows as the needle actuation handle iswithdrawn from its distal position to its proximal position.
 12. Thevessel closure device of claim 1 further comprising one or morealignment marks positioned on an exterior surface of a distal end of thehousing, each alignment mark being located at a pre-selected rotationalposition relative to the needles.
 13. The vessel closure device of claim12, wherein a first one of the one or more alignment marks is verticallyaligned with the needles.
 14. The vessel closure device of claim 13,wherein a second one of the one or more alignment marks is located at anangle of about 60 degrees in a clockwise direction relative to the firstone of the one or more alignment marks.
 15. The vessel closure device ofclaim 14, wherein a third one of the one or more alignment marks islocated at an angle of about 60 degrees in a counter-clockwise directionrelative to the first one of the one or more alignment marks.
 16. In avessel closure device for closing an opening or puncture in a vesselwall having an elongate shaft having a longitudinal axis, a housingpositioned at the proximal end of the shaft, a flexible, atraumaticmonorail guidebody positioned at the distal end of the shaft, and a pairof needles located within the shaft that can be selectively advancedthrough the vessel wall adjacent to the opening, an improved actuationand control mechanism for the vessel closure device comprising: one ormore alignment marks positioned on an exterior surface of a distal endof the housing, each alignment mark being located at a pre-selectedrotational position relative to the needles.
 17. The vessel closuredevice of claim 16, wherein a first one of the one or more alignmentmarks is vertically aligned with the needles.
 18. The vessel closuredevice of claim 17, wherein a second one of the one or more alignmentmarks is located at an angle of about 60 degrees in a clockwisedirection relative to the first one of the one or more alignment marks.19. The vessel closure device of claim 18, wherein a third one of theone or more alignment marks is located at an angle of about 60 degreesin a counter-clockwise direction relative to the first one of the one ormore alignment marks.
 20. In a vessel closure device for closing anopening or puncture in a vessel wall having an elongate shaft having alongitudinal axis, a housing positioned at the proximal end of theshaft, a flexible, atraumatic monorail guidebody positioned at thedistal end of the shaft, a foot articulatably mounted proximate thedistal end of the shaft, the foot being movable between a first, parkedposition, in which the foot is substantially aligned along the axis ofthe shaft, and a second, deployed position, in which the foot extendslaterally away from the shaft, the foot having a first and a second end,the first end and the second end each having a needle receptacle with acuff positioned therein, a length of suture located within the foot andextending between the cuffs, and a pair of needles located within theshaft that can be selectively advanced through the vessel wall adjacentto the opening and into the cuffs located in the needle receptacles inthe first and second ends of the foot, and that can be selectivelywithdrawn thereby drawing the suture through the vessel wall adjacent tothe opening, an improved actuation and control mechanism for the vesselclosure device comprising: a foot actuation handle operatively coupledto the foot, the foot actuation handle being selectively moveablelinearly along the axis of the device between a distal position wherebythe foot is positioned in its first, parked position, and a proximalposition whereby the foot is positioned in its second, deployedposition, the foot actuation handle comprising a pair of handles thatextend laterally from opposing sides of the housing, wherein the footactuation handle is configured to be grasped and manipulated by a pairof fingers of one hand of a user, and wherein the foot is deployed byaxial movement of the foot actuation handle in the proximal directionrelative to the needle actuation handle; a needle actuation handleoperatively coupled to the needles, the needle actuation handle beingselectively movably linearly along the axis of the device between aproximal position wherein the needles are located within the shaft and adistal position wherein the needles are advanced to engage the cuffs,wherein the needle actuation handle is configured to be engaged andselectively manipulated by a thumb of the same one hand of the user, andwherein, once the foot is deployed by proximal movement of the footactuation handle, the needles are deployed into engagement with the footby axial movement of the needle actuation handle in the distal directionrelative to the foot actuation handle; a first interlock mechanism thatprevents the needle actuation handle from being advanced from itsproximal position when the foot is positioned in its first, parkedposition, but allows the needle actuation handle to be advanced from itsproximal position to its distal position after the foot is moved to itssecond, deployed position; a second interlock mechanism that temporarilylocks the foot actuation handle into place when it is moved from itsdistal position to its proximal position, wherein the second interlockmechanism automatically releases the foot actuation handle from itsproximal position after the needle actuation handle is returned to itsproximal position from its distal position; and one or more alignmentmarks positioned on an exterior surface of a distal end of the housing,each alignment mark being located at a pre-selected rotational positionrelative to the needles.